FAQs

For the Institutional Biosafety Committee

Which legislation relates to biosafety regarding genetic manipulation?

The Gene Technology Act 2000 (The Act) regulates all biosafety in Australia.

What does the legislation regulate?

The legislation regulates all "dealings" with "GMOs". The legislation prohibits all dealings with GMOs, subject to a system of authorisations described in the legislation. A person who deals with a GMO without an appropriate approval is guilty of an offence under the legislation.

What is A GMO?

"Genetically modified organism" (or GMO) is defined in the Act to mean either:

a) an organism that has been modified by gene technology;

b) an organism that has inherited traits from an organism (the initial organism) being traits that occurred in the initial organism because of gene technology; or

c) anything declared by the regulations to be a genetically modified organism, or that belongs to a class of things declared by the Regulations to be genetically modified organisms; but does not include:

d) a human being, if the human being is covered by paragraph (a) only because the human being has undergone somatic cell gene therapy; or

e) an organism declared by the Regulations not to be a genetically modified organism, or that belongs to a class of organism declared by the Regulations not to be genetically modified organisms.

The Act defines gene technology as the modification of genes or other genetic material by any technique aside from:
a) sexual reproduction; or
b) homologous recombination; or

c) any other technique specified in the regulations.

What is a "dealing" with a GMO?

"Deal with" in relation to a GMO is defined in the Act to mean:
a) conduct experiments with the GMO;
b) make, develop, produce or manufacture the GMO;
c) breed the GMO;
d) propagate the GMO;
e) use the GMO in the course of manufacture of a thing that is not the GMO;
f) grow, raise or culture the GMO; or
g) import the GMO; and includes the possession, use, transport or disposal of the GMO for the purposes of, or in the course of, a dealing mentioned in any of the paragraphs (a) to (g).

See OGTR Factsheet

What is not regulated under the legislation?

The Act does not regulate:

a)         human beings, if the human being is a GMO only because they have undergone somatic cell gene therapy;
b)         somatic cell nuclear transfer (cloning) if the transfer does not involve genetically modified material; and
c)         organisms that are prescribed in the Regulations as not being GMOs.

What types of approvals are there?

The legislation prohibits all dealings with GMOs unless the dealings with GMOs are "approved" in one of four ways.

Subject to certain conditions and requirements being complied with, a person may deal with a GMO if the dealings are exempt dealings with GMOs - these are dealings that have been assessed over time as posing negligible risks. Such dealings do not require licensing because the dealings are known to pose low risk. As an additional precautionary measure, exempt dealings must be contained within a facility and must not involve the intentional release of the GMO into the environment.

Notifiable Low Risk Dealings (NLRDs) are dealings that have been assessed over time as posing low risks provided certain risk management conditions are complied with. NLRDs must be notified to the Regulator; conducted within a facility certified to be at least PC2; undertaken within an Accredited Organisation; and if transported, must be transported in accordance with Guidelines issued by the Regulator for the transport of GMOs. NLRDs with GMOs must not be released into the environment.

Licences - all dealings with GMOs (that are not exempt, NLRDs or on the GMO Register) will need to be licensed by the Regulator. There are two types of licences that may be issued by the Regulator - licences for dealings that do not involve the intentional release of a GMO into the environment and licences for dealings that do involve the intentional release of a GMO into the environment.

GMO Register - dealings with GMOs may be entered on the GMO Register once they have been licensed for a certain period of time. Dealings will not be entered onto the Register until the Regulator is satisfied that the dealings are sufficiently safe that they can be undertaken by anyone, and that safety does not depend on oversight by a licence holder.

Do I need approval for exempt work such as cloning a gene in E.coli or doing molecular marker work?

No. Recent changes to the Gene Technology Act 2000 mean that exempt work needs only to be notified to the Institutional Biosafety Committee (IBC). It is important that such notification occur well prior to commencing the proposed work, in case the IBC deems that your work is notifiable, in which case an authority will need to be secured.

I have never filled out any approvals for GM work, where do I begin?

Consult the rest of the IBC web site for an introduction then contact the Laboratory Manager for further advice, or the University Ethics Officer.

How do I know when IBC meetings are scheduled, and when do I need to submit my application?

IBC meeting dates are on the IBC web page. Applications for Exempt Dealings and Notifiable Low Risk Dealings may be submitted at any time. Applications for Licensed Dealings need to be submitted 2 weeks before each meeting.

How soon after the IBC meeting can I expect feedback about my approval?

Normally you will be contacted within about 5 working days.

I would like to change direction in my research, is it OK to amend my current NLRD?

Yes, you may make changes (eg add genes or different host/vector systems, change facilities or personnel) to your original NLRD approval. As the IBC maintains a register of NLRD data, it is requested that you advise the Ethics and Compliance Officer of your changes by email to ensure that the registers are accurate should an audit be conducted.

I am leaving the University. Is there anything special I need to do?

Yes, you need to clear out fridges and freezers and dispose of any unwanted material In accord with the provisions of the Gene Technology Act 2000. Any material being left behind should be catalogued, stored in accord with the Act. Staff remaining in the laboratory should know what the material is and which current proposal covers its storage. If you are taking GM material with you, ensure you have notified the relevant advisors, and that the institution to which you are moving has an OGTR approval in place to cover future work.

I have just received my advice to proceed for my licenced work do I need to do any thing special before I begin?

Yes, you and all your staff and collaborators must read and sign off that they understand the conditions of the licence. You should make copies of the licence and forward to staff at other sites specified in the licence and make sure they know they must understand and read. This must all be dated as well as signed.

Can I homogenise transgenic animal tissues that are not infectious outside the biosafety cabinet since I wish to keep my biosafety cabinet clean for tissue culture work?

Yes. The OGTR will allow this, provided the tissues are not infectious and pose minimal risk to people or the environment.

When is approval needed for non-GM work?

Biosafety approval is needed for work that the IBC considers high risk, for example, working with organisms in Risk Groups 3 and 4, working with infected or potentially infected animals.

Do I need Biosafety approval for working with human blood and tissues?

No. Not unless you know it contains high risk material as detailed in the previous question.

Do I need Biosafety approval to collect and handle bats or other infectious/ poisonous animals?

Yes.

Do I need a PC2 lab?

The OGTR regulations state that anyone doing non Exempt OGTR work must use a PC2 lab. Contact a Laboratory Manager or the Ethics and Compliance Officer for more details.

I do not do GM work but I work in a PC2 lab registered with the OGTR. Do I have to comply with their Regulations for PC2 work?

Yes. This is in their Act and you should be trained and signed off by the supervisor of that facility that you have done the required training and fully understand it.

Can I wear my laboratory coat between a PC2 facility and an instrument room (for example, across the hallway)?

The OGTR has given permission for laboratory coats to be placed over your arm and carried to another facility outside the PC2 laboratory.

I wish to increase the size of my laboratory by including an adjoining office space. Do I need to do anything before I contact Facilities Management?

Yes. Altering or decommissioning certified facilities requires specific processes. In the first instance you need to contact the Ethics Officer and a Laboratory Manager for initial process advice.

What are the requirements for transporting biological material?

1. Infectious and Diagnostic material
Biological material whether infectious or diagnostic, belongs to Class 6.2 of Dangerous Goods. This means there are implications for both packaging and transport of this material. The packaging requirements are different for Air, Post or Surface (Road and Rail) transport.
It is essential that staff explain the importance of adequate packaging to members of the public if they are sending biological material to the University for analysis. Mail room staff should not be expected to handle packages that may be contaminated or appear to be contaminated, regardless of the material in the package.

Surface (Road and Rail)

• There are Insurance implications for private car use
• An Australian Standard is currently being developed
• Queensland Transport Requires training (book through TEDI)

Air
If you send infectious or diagnostic material by Air the material has to be packed by a qualified person. Training for packaging to IATA (International Air Traffic Authority) requirements can be organized through the Ethics Officer. This course has to be accredited by CASA and the University is required to keep all training records of staff that have been trained. The certification upon completing the course is valid for 2 years only.

Post
Australia Post has a Postal guide that details packaging requirements.

2. Genetically Modified Material
The OGTR requires compliance with their Guidelines For Transport Of GMOs as well as any relevant transport authorities such as IATA, the Postal Guide or Dangerous Goods.